FDA Actions
The FDA has approved apalutamide for the treatment of non-metastatic castration-resistant prostate cancer. The drug is a nonsteroidal androgen receptor inhibitor and is the first androgen receptor inhibitor that is approved for non-metastatic disease. Also, this is the first oncolytic drug to be approved using metastasis-free survival as an endpoint, which the FDA touts as one of several new “novel endpoints to expedite important therapies to the American public.” Safety and efficacy of apalutamide was based on a randomized, clinical trial of 1,207 patients with non-metastatic, castration-resistant prostate cancer. All patients had received gonadotropin-releasing hormone analog therapy or undergone surgical castration. Median metastasis-free survival was 40.5 months with apalutamide vs. 16.2 months for placebo. The agency granted the drug priority review. Apalutamide is marketed as Erleada.
The FDA has expanded the indication for durvalumab (Imfinzi) to include treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are unresectable and whose cancer has not progressed after chemoradiation, the first drug approved for this niche indication. Durvalumab binds PD-1/PD-L1 and is approved for certain patients with locally advanced or metastatic bladder cancer. Approval was based on a trial of 713 patients with unresectable NSCLC whose cancer had not progressed after completing chemoradiation. The median progression-free survival for patients taking durvalumab was 16.8 months compared to 5.6 months for patients receiving a placebo.
In this section: The agency approves a new drug for prostate cancer and expands the indication for a non-small cell lung cancer treatment.
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